N/A Completed N=18 Randomized Single-blind Treatment

RCT on Interactive Computer Play on Trunk Control in CP

Cerebral Palsy · Exercise Therapy · Postural Balance

Source: ClinicalTrials.gov NCT02975804 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcomePrimary: Segmental Assessment on Trunk Control-static — 8; 8 score on a scale — p=< 0.05

Summary

Objectives: This proposal is to investigate the effect of a 6-week training programme using an Interactive computer play (ICP) on the trunk control, balance and gross motor function in children with cerebral palsy (CP). Hypothesis to be tested: The trunk control, balance and gross motor function of children with CP will be significantly improved after the ICP programme. Design and subjects: 20 children (6 to 12 years old) with CP will be recruited in this pilot randomised controlled trial. The children will be randomly allocated into a control or treatment group (10 children in each arm). Study instruments: Tymo is a wireless force plate used for assessment and training. Intervention: An ICP program will be set up using the Tymo. The child uses their trunk movements in the ICP in sitting during the intervention. The children will receive the intervention 4 times/week, 20 minutes/session for 6 weeks. All children will be assessed at the beginning, 3, 6 and 12 weeks post-intervention. Main outcome measures: * Segmental Assessment on Trunk control * Pediatric Reach Test * Gross Motor Function Measure Item Set (GMFM IS) * 2-minute walk test Data analysis: As a pilot study, 20 children will be recruited for this study. Independent t-test or Mann Whitney U test will be used to compare the continuous and ordinal results between the intervention and control groups. Expected results: The trunk control, balance and gross motor function of children with CP will be significantly improved after the intervention. Clinical significance and potential of the study: This is clinical trial to examine the effectiveness of a new intervention, a kind of interactive computer play training module, on training the trunk control for children with cerebral palsy. If the intervention is proven effective, it may be an adjunct to the conventional Physiotherapy to children with movement disorders in enhancing their trunk control. Better trunk control will in turn improve the daily function for these children as their sitting and standing balance is improved. In a long run, these children will not rely on expensive seating equipment to maintain their balance during schooling and at home.

Outcome Measures

Outcome	Result	p-value
PRIMARY Segmental Assessment on Trunk Control-static	8; 8	< 0.05 sig
PRIMARY Segmental Assessment on Trunk Control-active	7; 8	< 0.05 sig
PRIMARY Segmental Assessment on Trunk Control-reactive	6; 6	< 0.05 sig
SECONDARY Pediatric Reach Test-forward Sitting	8.28; 10.72	< 0.05 sig
SECONDARY Pediatric Reach Test- Right Sitting	8.5; 10.5	< 0.05 sig
SECONDARY Pediatric Reach Test- Left Sitting	8.94; 10.06	< 0.05 sig
SECONDARY Pediatric Reach Test- Forward Standing	—	—
SECONDARY Pediatric Reach Test- Right Standing	—	—
SECONDARY Pediatric Reach Test- Left Standing	—	—
SECONDARY Gross Motor Function Measure Item Set- Total Score	9.06; 9.94	< 0.05 sig
SECONDARY 2-minute Walk Test	8.11; 10.89	< 0.05 sig
SECONDARY Height	—	—
SECONDARY Weight	—	—
SECONDARY Gross Motor Function Measure 88- Lying	—	—
SECONDARY Gross Motor Function Measure 88- Sitting	—	—
SECONDARY Gross Motor Function Measure 88- Crawling and Kneeling	—	—
SECONDARY Gross Motor Function Measure 88- Standing	—	—

Eligibility Criteria

Inclusion Criteria

Children with a diagnosis of CP will be of GMFCS levels III to IV, who in general, require walking aid (level III) during ambulation and with limited walking ability (level IV).[4] Aiming to achieve a higher homogeneity of the recruited children, for those with level III, only those requiring physical assistance to climb stairs will be recruited and so it is believed that only those with lower motor ability, i.e. similar to level IV, will be included.
Children, with non-CP physical disabilities, will have similar gross motor function as in (1).
Aged from 6 to 12 years old and
Able to follow instructions to interact in simple computer games

Exclusion Criteria

Children with epilepsy/ seizures that could be elicited by flashing lights or sudden loud noises from computer screens

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02975804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.